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NCT07668336RecruitingPhase 3

A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes

A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Once-Daily Oral Orforglipron Compared With Once-Weekly Dulaglutide in Pediatric Participants 10 to Less Than 18 Years of Age With Type 2 Diabetes

Source: ClinicalTrials.gov · Last updated 19 Oct 2026

Brief summary (registry, in English)

This study looks at how well a medicine called orforglipron works compared to another medicine called dulaglutide in pediatric participants aged 10 to less than 18 years with type 2 diabetes. The study will also check how safe these medicines are and how the body processes them. Participation in the study will last about 61 weeks.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
170 (estimated)
First submitted
22 Jun 2026
Start date
8 Jul 2026
Primary completion date
31 Mar 2030
Lead sponsor
Eli Lilly and Company
NCT number
NCT07668336
EU CT number
2025-524811-35-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 170
  • From 8 Jul 2026 to the primary completion date, 31 Mar 2030
  • 71 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Have had at least one episode of severe hypoglycemia and/or at least one episode of hypoglycemic unawareness within the last 6 months before screening
  • Have been treated with prescription drugs or over-the-counter medications that promote weight loss within 90 days prior to screening

Other illness

  • Have type 1 diabetes
  • After the type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome
  • Have a history of pancreatitis or gallbladder disease
  • Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)

Lab values

  • Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or (SGLT2) inhibitors within 90 days prior to screening

Who the study is looking for

  • Have type 2 diabetes treated with diet and exercise and metformin and/or basal insulin
  • Have HbA1c \> 6.5% to ≤ 11.0% at screening
  • Have a body weight ≥50 kilograms (kg) (110 pounds) and a body mass index (BMI) of \>85th percentile

Age in the registry: 10 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (71)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Saint Luc
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BrusselsBelgiumRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Instituto de Pesquisa Clínica de Campinas
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CampinasBrazilNot yet recruiting
Centro de Pesquisa Sao Lucas
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CampinasBrazilNot yet recruiting
Cendi - Endocrinologia e Diabetes
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GoiâniaBrazilNot yet recruiting
Instituto Mederi de Pesquisa e Saude
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Passo FundoBrazilNot yet recruiting
Instituto da Crianca com Diabetes
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Porto AlegreBrazilNot yet recruiting
IBTED - Tecnologia e Educação em Diabetes
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São PauloBrazilNot yet recruiting
Instituto de Pesquisa Clinica
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São PauloBrazilNot yet recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Universitario Regional de Málaga
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MálagaSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
Hull Royal Infirmary
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HullUnited KingdomNot yet recruiting
Alder Hey Children's Hospital
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LiverpoolUnited KingdomNot yet recruiting
Royal London Hospital
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LondonUnited KingdomNot yet recruiting
Avron Hospitals
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AhmedabadIndiaNot yet recruiting
Gujarat Endocrin Pvt Ltd
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AhmedabadIndiaNot yet recruiting
Jawaharlal Nehru Medical College
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AligarhIndiaNot yet recruiting
All India Institute of Medical Sciences
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BhubaneswarIndiaNot yet recruiting
Endolife Speciality Hospitals
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GunturIndiaNot yet recruiting
King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College
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MumbaiIndiaNot yet recruiting
Harmony Health Hub
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NashikIndiaNot yet recruiting
All India Institute of Medical Sciences
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New DelhiIndiaNot yet recruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
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AnconaItalyRecruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
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FlorenceItalyRecruiting
IRCCS Istituto Giannina Gaslini
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GenoaItalyRecruiting
Università degli Studi di Messina
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MessinaItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyRecruiting
Azienda Ospedaliera Universitaria Integrata Verona
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VeronaItalyRecruiting
Nihon University Hospital
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Chiyoda-kuJapanNot yet recruiting
Fukuoka Children's Hospital
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FukuokaJapanRecruiting
Saitama Medical University Hospital
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IrumaJapanNot yet recruiting
Shiga General Hospital
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MoriyamaJapanRecruiting
Niigata University Medical & Dental Hospital
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NiigataJapanRecruiting
Osaka City General Hospital
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OsakaJapanRecruiting
Saitama City Hospital
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SaitamaJapanRecruiting
Sendai City Hospital - Asutonagamachi
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SendaiJapanRecruiting
Shizuoka Children's Hospital
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ShizuokaJapanRecruiting
Urakami Pediatric Endocrinology and Diabetes Clinic
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TokyoJapanRecruiting
Juntendo University Urayasu Hospital
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UrayasuJapanNot yet recruiting
Soon Chun Hyang University Bucheon Hospital
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Bucheon-siSouth KoreaNot yet recruiting
Kyungpook National University Chilgok Hospital
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DeaguSouth KoreaNot yet recruiting
Chungnam national university hospital
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JungguSouth KoreaNot yet recruiting
Seoul National University Bundang Hospital
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SeongnamSouth KoreaNot yet recruiting
Seoul National University Hospital
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SeoulSouth KoreaNot yet recruiting
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
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Ciudad MaderoMexicoNot yet recruiting
Centro de Investigacion Medica de Occidente, S.C.
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GuadalajaraMexicoNot yet recruiting
Clínica García Flores SC
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MonterreyMexicoNot yet recruiting
UBAM Unidad Biomedica Avanzada Monterrey
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MonterreyMexicoNot yet recruiting
Centro de investigación y control metabólico
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MonterreyMexicoNot yet recruiting
China Medical University Hospital
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TaichungTaiwanNot yet recruiting
Chang Gung Medical Foundation-Linkou Branch
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TaoyuanTaiwanNot yet recruiting
Medical Research Partners
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AmmonUnited StatesRecruiting
Children's Healthcare of Atlanta - Center for Advanced Pediatrics (CAP)
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AtlantaUnited StatesNot yet recruiting
Gadolin Research
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BeaumontUnited StatesRecruiting
Driscoll Children's Hospital
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Corpus ChristiUnited StatesRecruiting
CenExel iResearch, LLC
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DecaturUnited StatesRecruiting
Proactive Clinical Research LLC
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EdinburgUnited StatesRecruiting
Vanderbilt Health One Hundred Oaks
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NashvilleUnited StatesNot yet recruiting
Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology
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SacramentoUnited StatesNot yet recruiting
Rady Children's Hospital
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San DiegoUnited StatesNot yet recruiting
Consano Clinical Research, LLC
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Shavano ParkUnited StatesRecruiting
Frontier Clinical Research, LLC
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SmithfieldUnited StatesRecruiting
Stamford Therapeutics Consortium
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StamfordUnited StatesRecruiting
SUNY Upstate Medical University
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SyracuseUnited StatesNot yet recruiting
Advantage Clinical Trials
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The BronxUnited StatesRecruiting
Cotton O'Neil Diabetes & Endocrinology
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TopekaUnited StatesRecruiting
Central States Research
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TulsaUnited StatesRecruiting
Victoria Clinical Research Group
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VictoriaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.